MAUDE Adverse Event Report: SYNTHES MONUMENT; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown radial head prosthesis /unknown lot.Part and lot number are unknown; udi number is unknown.Since this is an external fixation and was placed on the exterior, no official implant and explant date is needed.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4): an x-ray on an unknown date revealed that the devices were loose.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a patient who underwent revision surgery on (b)(6) 2015, three days after the initial implantation of the radial head prosthesis system on (b)(6) 2015, had an external fixator placed on (b)(6) 2015.An x-ray on an unknown date revealed that the devices were loose.Therefore, the surgeon chose to add the external device for stability in addition to the implants.It was further reported that the surgeon removed the external fixator on (b)(6) 2015 as planned.No further action was taken until (b)(6) 2016 when the radial head and stem were removed due to looseness of the devices.Related complaint (b)(4) captures the first revision surgery held on (b)(6) 2015 and related complaint (b)(4) addresses the final hardware explant on (b)(4) 2016.This report is for an unknown radial head prosthesis.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Complaint was reviewed and determined to be a part of recall.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6367977
• MDR Text Key: 68748433
• Report Number: 2520274-2017-10674
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention